Amoxicillin is a penicillin antibiotic. Omeprazole is a proton pump inhibitor that decreases stomach acid. Rifabutin is an antibiotic that fights bacteria.

Amoxicillin, omeprazole, and rifabutin is a combination medicine that is used to treat Helicobacter pylori (H. pylori) infection in adults.

Amoxicillin, omeprazole, and rifabutin may also be used for purposes not listed in this medication guide.

Tell your doctor if you have ever had an allergic reaction to an antibiotic medicine.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food and a full glass (8 ounces) of water.

Swallow the capsule whole and do not crush, chew, break, or open it.

For up to 14 days after you last took amoxicillin, omeprazole, and rifabutin, this medicine can affect the results of certain medical tests, including a drug-screening urine test. You may have false results. Tell the laboratory staff that you use amoxicillin, omeprazole, and rifabutin. Tell any doctor who treats you that you are using amoxicillin, omeprazole, and rifabutin.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Amoxicillin, omeprazole, and rifabutin will not treat a viral infection such as the flu or a common cold.

Store this medicine in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Helicobacter pylori Infection:

Amoxicillin 250 mg-omeprazole 10 mg-rifabutin 12.5 mg oral capsules: 4 capsules orally every 8 hours
-Duration of therapy: 14 days

Comments:
-Capsules should be swallowed with at least 8 ounces of water.
-This drug should be used to treat infections proven/strongly suspected to be caused by susceptible bacteria.
-Antibiotic selection should be determined by local bacterial resistance, duration of treatment, and appropriate use.

Use: Treatment of Helicobacter pylori infection

You should not use amoxicillin, omeprazole, and rifabutin if you are allergic to amoxicillin (Amoxil, Augmentin), omeprazole (Prilosec), or rifabutin (Mycobutin).

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with amoxicillin, omeprazole, and rifabutin. Your doctor may change your treatment plan if you also use:

• delavirdine;

• rilpivirine (Juluca); or

• voriconazole.

Tell your doctor if you have ever had:

• an allergic reaction to an antibiotic medicine;

• lupus;

• liver disease;

• kidney disease; or

• mononucleosis.

Amoxicillin, omeprazole, and rifabutin may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

This medicine can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using amoxicillin, omeprazole, and rifabutin, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

This medicine may affect fertility (ability to have children) in men.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Amoxicillin, omeprazole, and rifabutin is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms include drowsiness, confusion, blurred vision, nausea, vomiting, dry mouth, sweating, or fast heartbeats.

Do not take amoxicillin, omeprazole, and rifabutin with alcohol.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Avoid wearing soft contact lenses. The rifabutin in this medicine can discolor your tears and could permanently stain contact lenses.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Amoxicillin, omeprazole, and rifabutin may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• a light-headed feeling, like you might pass out;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• eye pain or redness, vision problems, seeing spots, your eyes may be more sensitive to light;

• flu-like symptoms--fever, chills, sweating, tiredness, body aches, vomiting, chest pain, cough, feeling short of breath;

• kidney problems--urinating more or less than usual, fever, nausea, vomiting, blood in your urine, confusion, swelling, rapid weight gain; or

• lupus-like symptoms--muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight.

Common side effects of amoxicillin, omeprazole, and rifabutin may include:

• red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;

• indigestion, stomach pain, nausea, vomiting, diarrhea;

• headache;

• discolored urine;

• sore throat;

• rash; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect the blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect amoxicillin, omeprazole, and rifabutin, especially:

• allopurinol;

• clopidogrel;

• digoxin;

• methotrexate;

• St. John's wort;

• tacrolimus;

• an antibiotic--clarithromycin, rifampin, telithromycin;

• antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;

• antiviral medicine to treat HIV/AIDS--fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir; or

• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete and many other drugs may affect amoxicillin, omeprazole, and rifabutin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.